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Pulmonary Arterial Hypertension (PAH)Phase 1NCT06932198

Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)

A Phase 1 study testing Selexipag Film Coated Tablets and Uptravi® Film Coated Tablets in people with Pulmonary Arterial Hypertension (PAH), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in healthy subjects under fed conditions. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Arterial Hypertension (PAH)
What is being tested?
Selexipag Film Coated Tablets and Uptravi® Film Coated Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteJordan
Study dates
9 Jan 2025to 25 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is Caucasian \& aged between eighteen to fifty (18-50), both inclusive.
  • The subject is within the limits for his/her height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
  • The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
  • The results of medical history, physical examination, vital signs \& conducted medical laboratory tests are normal as determined by the clinical investigator.
  • The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
  • There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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  • The subject is able to understand and willing to sign the informed consent form.
  • For female subjects: negative serum pregnancy test and the married woman is using two reliable contraception methods and should be non-lactating.
  • The subject has normal cardiovascular system \& normal ECG with normal QT interval corrected for heart rate according to Bazett's formula.
  • The subject kidney and liver (AST \& ALT enzymes) functions tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the clinical investigator as clinically not significant).
  • The subject Haematology test results are within normal range \& RBC indices are within 5% of the normal range.
  • The subject blood pressure is ≥ 110/70 mmHg before dosing.
  • The subject has normal thyroid gland function.

Who cannot join

  • The subject is a heavy smoker (more than 10 cigarettes per day).
  • The subject has a history of or concurrent abuse of alcohol.
  • The subject has a history of or concurrent abuse of illicit drugs.
  • The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
  • The subject has suffered an acute illness one week before dosing.
  • The subject has been hospitalized within three months before the study or during the study.
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  • The subject is on special diet (for example subject is vegetarian.)
  • The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 hours after dosing in both study periods.
  • The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
  • The subject has taken grapefruit/orange containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
  • The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
  • The subject has donated blood within 80 days before first dosing.
  • The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal, ocular or psychiatric diseases.
  • The subject has consumed drugs that may affect pharmacological or pharmacokinetic properties of Selexipag (for example: gemfibrozil, clopidogrel, deferasirox, teriflunomide, rifampicin, carbamazepine, phenytoin, valproic acid, probenecid, fluconazole, lopinavir/ritonavir). two weeks before dosing, during the study and two weeks after dosing.
  • The subject has recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting.
  • Note: Subjects, who were screened for another study and were not enrolled, might be recruited for this study provided they meet the acceptance criteria of the study.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • ACDIMA Center

    Amman, 11190

Other trials in Jordan

About this study

Official title: Randomized, Single Oral Dose, Two-period, Two-treatment, Two-sequence Open-label, Crossover, Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in Healthy Subjects Under Fed Conditions

Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in healthy subjects under fed conditions.

Being tested
Selexipag Film Coated Tablets, Uptravi® Film Coated Tablets
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selexipag Film Coated TabletsDrug

    1 tablet

  • Uptravi® Film Coated TabletsDrug

    1 tablet

Study groups in NCT06932198
Study groupRoleWhat they receive
Selexipag Film Coated TabletsExperimentalSelexipag 400mcg Film Coated Tablets (400mcg Selexipag)
Receives: Drug: Selexipag Film Coated Tablets
Uptravi® Film Coated TabletsActive comparatorUptravi® 400mcg Film Coated Tablets (400mcg Selexipag)
Receives: Drug: Uptravi® Film Coated Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration (Cmax)

    two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data Cmax

    Measured: 72 hours

  2. AUC from time 0 to last collection time t (AUC0 - t)

    two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data AUC0-t

    Measured: 72 hours

Secondary outcomes (2)

  1. Time to reach maximum concentration Cmax (Tmax)

    Descriptive Statistics

    Measured: 72 hours

  2. half-life (Thalf)

    Descriptive Statistics

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start9 Jan 2025
  3. Primary completion3 Mar 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06932198
Sponsor's protocol ID
1358-2024
Status last verified
Dec 2024
First submitted
10 Apr 2025
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selexipag Film Coated Tablets and Uptravi® Film Coated Tablets in people with Pulmonary Arterial Hypertension (PAH), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration (Cmax) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06932198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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